Development
Intercept Pharma terminates Phase II trial of farnesoid X receptor agonist INT-787 in severe alcohol-associated hepatitis
Intercept Pharmaceuticals has terminated its Phase II proof-of-concept trial of INT-787, a selective farnesoid X receptor (FXR) agonist, in severe...
Kivu Bio's CEACAM5-directed ADC KIVU-305 enters Phase I for solid tumors
Kivu Bioscience initiates first-in-human Phase I trial of KIVU-305, a CEACAM5-directed ADC, in adults with locally advanced or metastatic solid tumors, with...
Pfizer terminates Phase I trial of Seagen-acquired PD-L1 targeted TLR7 agonist ISAC
Pfizer has terminated a Phase 1 clinical trial evaluating PF-08046037 (also known as SGN-PDL1iT), an immunostimulatory antibody conjugate targeting PD-L1,...
Create Medicines' in vivo NK CAR therapy shows early promise in HER2-positive solid tumors
CREATE Medicines, the Cambridge, Massachusetts-based biotech, dosed the first patient in a Phase I/II study of MT-304, an mRNA-LNP-delivered in vivo CAR...
Novo Nordisk's oral semaglutide shows efficacy in Phase III pediatric type 2 diabetes trial
Novo Nordisk (Copenhagen: NOVO B) reported that oral semaglutide reduced HbA1c by 0.83% versus placebo at 26 weeks in children and adolescents with type 2...
Context Therapeutics puts Nectin-4 × CD3 TCE into first clinical study for triple-negative breast cancer
Context Therapeutics (Nasdaq: CNTX) has registered a first-in-human Phase I clinical trial for CT-202, a Nectin-4 × CD3 bispecific T cell engaging antibody,...
Mozart Therapeutics' potential first-in-class CD8 modulator shows promise in type 1 diabetes
Mozart Therapeutics reported interim Phase Ib results for MTX-101 in adults with Stage 3 type 1 diabetes, with data from five patients presented at the 21st...
BioAge Labs' NLRP3 inhibitor shows strong inflammation reduction in obesity with elevated systemic inflammation
BioAge Labs reported Phase I results for BGE-102, an oral small-molecule NLRP3 inhibitor, in participants with obesity and elevated systemic inflammation,...
Roche/Genentech's Enspryng set for approval filings in MOGAD after strong Phase III
Genentech reported that satralizumab (Enspryng) reduced the risk of relapse by 68% compared to placebo in the Phase III METEOROID study in myelin...
Ractigen posts early RAG-17 ALS data with strong biomarker signals but limited patient numbers
Ractigen Therapeutics reported Phase I data from its RAG-17 program in SOD1-ALS showing an 81.2% reduction in plasma neurofilament light chain from a single...
Roche’s BTK inhibitor fenebrutinib posts Phase III MS win, overshadowed by deaths imbalance
Roche (SWX: RO; OTCQX: RHHBY) reported that fenebrutinib cut annualized relapse rates by 51.1% and 58.5% versus teriflunomide across two Phase III trials in...
Regeneron's cemdisiran meets primary endpoints in Phase III generalized myasthenia gravis trial
Regeneron Pharmaceuticals (Nasdaq: REGN) reported that cemdisiran, its investigational siRNA therapeutic, met both the primary and key secondary endpoints...
Lytix Bio's oncolytic peptide ruxotemitide shows benefit in checkpoint inhibitor-refractory melanoma
Lytix Biopharma reported final Phase II data for ruxotemitide (LTX-315) combined with pembrolizumab in checkpoint inhibitor-refractory advanced melanoma,...
Merck and Eisai's triplet and MK-1308A regimens fall short against Keytruda combo in RCC Phase III
Merck (NYSE: MRK) and Eisai reported that neither experimental combination regimen tested in the Phase III LITESPARK-012 trial met the dual primary...
AstraZeneca's ravulizumab aces endpoint in Phase III immunoglobulin A nephropathy trial
AstraZeneca's Alexion unit reported that ravulizumab (Ultomiris) met the proteinuria primary endpoint in a prespecified interim analysis of the Phase III I...
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